NDC 69396-041 Family Wellness Original

Family Wellness Bacitracin, Neomycin, Polymyxin B

NDC Product Code 69396-041

NDC CODE: 69396-041

Proprietary Name: Family Wellness Original What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Family Wellness Bacitracin, Neomycin, Polymyxin B What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
  • Drug uses not available

NDC Code Structure

  • 69396 - Trifecta Pharmaceuticals Usa Llc.

NDC 69396-041-01

Package Description: 1 TUBE in 1 BOX > 28.4 g in 1 TUBE

NDC Product Information

Family Wellness Original with NDC 69396-041 is a a human over the counter drug product labeled by Trifecta Pharmaceuticals Usa Llc.. The generic name of Family Wellness Original is family wellness bacitracin, neomycin, polymyxin b. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Trifecta Pharmaceuticals Usa Llc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Family Wellness Original Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BACITRACIN ZINC 400 [USP'U]/g
  • NEOMYCIN SULFATE 3.5 mg/g
  • POLYMYXIN B SULFATE 5000 [USP'U]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SQUALANE (UNII: GW89575KF9)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • CETYL ALCOHOL (UNII: 936JST6JCN)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Trifecta Pharmaceuticals Usa Llc.
Labeler Code: 69396
FDA Application Number: part333B What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-30-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Neomycin, Polymyxin, and Bacitracin Topical

Neomycin, Polymyxin, and Bacitracin Topical is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)

Why is neomycin, polymyxin, and bacitracin topical medication prescribed?
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and b...
[Read More]

* Please review the disclaimer below.

Family Wellness Original Product Label Images

Family Wellness Original Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (Each Gram Contains)

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings

Warnings For external use only.
Do not use ● in the eyes ● over large areas of the body
● if you are allergic to any of the ingredients.Ask a doctor before use if you have● deep or puncture wounds ● animal bites ● serious burns.Stop use and ask a doctor if ●
condition persists or gets worse
● you need to use longer than 1 week● a rash or other allergic reaction develops

Directions

● clean the affected area and dry thoroughly. ● apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily ● may be covered with a sterile bandage.

Inactive Ingredient

Inactive ingredient Cetyl Alcohol, Light Mineral Oil, White Petrolatum, Squalane, Stearic Acid, Vitamin E

Other Information

● To open: unscrew cap, pull tab to remove foil seal

● store at 20° to 25°C ( 68° to 77°F)
● see carton or tube for lot number and expiration date.

Otc - Questions

Questions? Call 1-888-296-9067 Weekdays: 9AM - 4PM EST

Other

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.500 Volvo Parkway, Chesapeake, VA. 23320NOT 100% SATISFIED?Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

* Please review the disclaimer below.